Puregraft Serene Breast Implant

GUDID 00850034511801

Saline Breast Implant

Bimini Technologies LLC

Saline-filled breast implant, internally-structured

• Primary Device ID: 00850034511801
• NIH Device Record Key: d9a2a042-9770-48a3-b6f4-ad8df737f1ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Puregraft Serene Breast Implant
• Version Model Number: 515CC
• Company DUNS: 076649467
• Company Name: Bimini Technologies LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter
• Total Volume: 515 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850034511788 [Primary]
GS1	00850034511801 [Package]; Contains: 00850034511788; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120011

FDA Product Code

• FWM: Prosthesis, Breast, Inflatable, Internal, Saline

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-05
• Device Publish Date: 2024-03-28

On-Brand Devices [Puregraft Serene Breast Implant]

• 00850034511931: Saline Breast Implant
• 00850034511924: Saline Breast Implant
• 00850034511894: Saline Breast Implant
• 00850034511863: Saline Breast Implant
• 00850034511825: Saline Breast Implant
• 00850034511801: Saline Breast Implant
• 00850034511771: Saline Breast Implant
• 00850034511757: Saline Breast Implant
• 00850034511672: Saline Breast Implant
• 00850034511658: Saline Breast Implant
• 00850034511627: Saline Breast Implant
• 00850034511399: Saline Breast Implant
• 00850034511337: Saline Breast Implant
• 00850034511153: Saline Breast Implant